JP2008520372A - 材料固定装置、システム及び方法 - Google Patents
材料固定装置、システム及び方法 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/08—Muscles; Tendons; Ligaments
- A61F2/0811—Fixation devices for tendons or ligaments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00862—Material properties elastic or resilient
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0409—Instruments for applying suture anchors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0412—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from suture anchor body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0414—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0427—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body
- A61B2017/0435—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0427—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body
- A61B2017/0437—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body the barbs being resilient or spring-like
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/08—Muscles; Tendons; Ligaments
- A61F2/0805—Implements for inserting tendons or ligaments
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/08—Muscles; Tendons; Ligaments
- A61F2/0811—Fixation devices for tendons or ligaments
- A61F2002/0847—Mode of fixation of anchor to tendon or ligament
- A61F2002/0852—Fixation of a loop or U-turn, e.g. eyelets, anchor having multiple holes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/08—Muscles; Tendons; Ligaments
- A61F2/0811—Fixation devices for tendons or ligaments
- A61F2002/0847—Mode of fixation of anchor to tendon or ligament
- A61F2002/0858—Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/08—Muscles; Tendons; Ligaments
- A61F2/0811—Fixation devices for tendons or ligaments
- A61F2002/0876—Position of anchor in respect to the bone
- A61F2002/0882—Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/08—Muscles; Tendons; Ligaments
- A61F2/0811—Fixation devices for tendons or ligaments
- A61F2002/0876—Position of anchor in respect to the bone
- A61F2002/0888—Anchor in or on a blind hole or on the bone surface without formation of a tunnel
Abstract
Description
本発明の例示の装置実施形態は、腱を骨に縫合固定する必要なしに、腱又は他の軟組織を骨に直接固定することを可能にする様々な骨アンカーを提供する。従来の骨アンカーは、一般的に、隣接した組織を骨にピン留めすることを可能にするタックであるか、又は、軟組織を骨に間接的に取付けるために骨に縫合を取付け且つその縫合を軟組織に取付ける縫合アンカーであった。本発明のインプラント実施形態は、腱又は他の軟組織を骨トンネル又は孔内に直接保持して安定化させるために、アンカー自体(取付けられた縫合でなはく)を用いる直接取付け手法を提供する。
直接式アンカーの挿入は、対応する機器トレイの使用で標準化することができる。最初の処置工程は、腱又は他の軟組織を挿入して直接式アンカーが固定される骨孔の正確な位置及び方向決めを可能にするガイドピンの使用を含む。適切な大きさのカニューレ挿入ドリルを、ガイドピンの上を伝わらせてドリル孔を生成するのに用いることができる。ドリルは、アンカーの正確な深さを可能にする深さ止めを有する。トレイは、直径3mm〜12mmまでの範囲の様々なドリル寸法を保持することができる。最後に、トレイは、ドリル孔内の骨に直接固定されることになる腱の直径を判断するのに用いる装置を有することができる。
本明細書に説明した例示の方法及び装置を用いて腱固定を実施するために、領域のアクセスのための部位及び/又は関節鏡ポータルの標準手術準備が行われる。処置を関節鏡的に実施する場合、関節は、関節鏡流体で拡張される。開口処置を用いるとき、装置は、片手で容易に操作して展開することができる。関節鏡処置のために、展開装置は、設けられた標準5、6、又は8mmのカニューレを通って関節内に導入される。カニューレ寸法の範囲は、2〜11mmになる。
この技術は、利用することができる腱の長さが限定される場合に用いられる。この技術は、腱の端部を準備し、それをアンカーに縫合するために開口外科的切開を必要とする。
〔B.二重腱ストランド技術〕
この技術は、利用することができる腱が豊富であり、又は腱がその中間点で固定を必要とする時に用いられる。
〔C.滑りアンカー技術〕
この技術は、骨トンネルの外に突出している腱の固定を可能にする。腱とアンカーの構成体を同時にトンネル内に押し込むのではなく、アンカーを展開前に腱に沿って(又は腱と共に)所定の位置に滑らせる。
〔D.腱板修復技術〕
この技術は、腱板縁を骨トンネル内に引き入れるプーリとして作用するインプラントの形状を用いる。
一部の腱の腱固定術は、腱の長さによって限定される。肘の末端二頭筋の修復は、この種類の処置の例である。この場合、腱は、展開アンカーと腱の間の2点圧縮を達成するのに十分長くない可能性がある。2点圧縮は、以下に説明するように、本発明の実施形態を用いる他の技術によって達成され、即ち、アンカーの周りの腱のループを形成することによって、直接式アンカーが腱の2つのセグメントに係合させ、腱を骨組織に直接押付ける。
多くの腱固定術処置は、同時に2つの腱ストランドの固定を必要とする。更に、一部の腱固定術処置は、同時に2つの腱を固定し、次に、必要でない腱のアームを切断することにより、更に容易に実施することができる。この変化は、2点の腱から骨への押付けを可能にし、治癒を促進する腱と骨組織の間の接触表面積を増加させる。
一部の外科的処置は、骨トンネル内で及び/又は腱ストランドが骨トンネルから延びるとき、腱ストランドの固定を必要とする。ここで腱は、両側から設けられており、異なる方向からの固定を必要とする。別の時には、腱を既に孔の中に挿入している場合があり、その現在の位置での単なる固定を必要とするであろう。修正アンカー(滑りアンカー)は、この固定を設けるために用いることができる。この種類の固定が必要である例は、ハームストリング前十字靱帯再建の脛骨固定及び肘側副靱帯再建の上腕骨固定である。
腱板断裂の修復は、このインプラントの独特な形状を利用して実施することができる。腱板断裂を修復してトラフにすることは、多くの場合に開口処置中に用いる技術であるが、関節鏡的に実施するのは困難である。このアンカーの形状は、滑り縫合技術を利用して腱板修復をトラフにするのを容易にする。
腱固定術アンカーは、軟組織対骨の固定を含む他の用途に用いることができることを認めるべきである。本明細書及び図面に示すように、本発明の実施形態は、人体構造に対して調整される。更に、本発明はまた、馬、犬、羊、及び豚、並びに無脊椎動物などの他の種における用途に調整することができる。当業者は、人間以外の動物に適合し又は適切であるように、必要以上の実験なしに本明細書に説明した例示の実施形態を再確認することができる。このような人間でない対象における用途の新しい構成も本発明の範囲及び精神に該当する。
図1A及び図1Bはそれぞれ、直接式腱アンカーの例示の実施形態を用いたハームストリング(膝腱)前十字靱帯(ACL)再建部の側面図及び側面断面図を示し、この実施形態は、ACL移植片の近位側を大腿骨11に固定し且つその遠位側を脛骨12に固定するのに使用されている。図2は、図1A及び図1Bに示すACL再建部の正面図を示す。図1A、図1B及び図2に示すように、例示の1つの直接式腱アンカー17は、脛骨12を貫通し且つ大腿骨11の中を部分的に通るように形成された骨ドリル孔18の中に腱アンカー17を挿入することによって、巻かれた2本のストランドハームストリング移植片13を大腿骨11に固定するのに用いられる。ハームストリング移植片ストランド13の自由端部を脛骨12に固定するための3つの直接式腱アンカー15が示されている。移植片を骨ドリル孔内に固定するのに、任意の数(1〜5)の直接式腱アンカーを用いることができることに注目すべきである。
アンカー及び展開器具構成要素は、弾性を有する、又は、変形可能であるのがよい。従って、アンカー又は展開器具構成要素は、様々な材料から製作することができ、係る材料は、例えば、形状記憶合金(例えば、ニッケルチタン(ニチノール))、形状記憶ポリマー、ポリマー(例えば、PTFE、ポリウレタン、ウレタン、シリコーン、ポリイミド、ポリプロピレン、ポリ乳酸、ポリグリコール酸、又は他の熱硬化性又は熱可塑性又はエラストマー性材料)、及び金属又は合金(例えば、チタン、CoCrMo、ステンレス鋼、その他)である。一部の実施形態では、装置アンカー構成要素は、吸収性であるのがよく、他の実施形態では、装置構成要素は、吸収性が限定された又は全くない特性を有していてもよい。本明細書に説明したアンカー構成要素は、部分的に1つの材料で作られてもよいし、全体的に1つの材料で作られてもよい。変形例として、アンカー又は展開器具の構成要素は、金属及び/又はポリマー構成要素で構成され、複合装置に製作されてもよい。例えば、小さい表面積で薄い金属又は金属合金構成要素は、ポリマー(例えば、ポリプロピレン)とインサート成形され、複合装置を生成することができる。
Claims (20)
- 軟質材料を硬質材料に結合させるための装置であって、
実質的に非円筒形のアンカーを有し、
前記アンカーに軟質材料が固着され、前記アンカーは、硬質材料に安定的に取付けられる、装置。 - 軟質材料は腱であり、硬質材料は骨である、請求項1に記載の装置。
- 前記アンカーは、骨内の内部空間に取付けられる、請求項2に記載の装置。
- 骨内の前記内部空間は、前記アンカーが圧入される孔を有する、請求項4に記載の装置。
- 前記アンカーは、壁を有し、この壁は、前記アンカーを骨内に導入する時の初期形態から、前記アンカーを骨内に楔式に押込んだ第2形態まで移動可能である、請求項2に記載の装置。
- 前記アンカーは、更に、前記骨内への前記アンカーの楔式の押し込みを助けるタブを有する、請求項2に記載の装置。
- 前記アンカーは、その外壁の少なくとも一部分が腱を骨の内側に押付けるように位置決めされる、請求項2に記載の装置。
- 腱を骨に結合させるための装置であって、
腱に固着されるアンカーを有し、
前記アンカーは、移動可能な本体部分を有し、この本体部分は、前記アンカーを骨孔内に移動させるのに使用される非固定初期位置から、前記アンカーを骨に安定的に取付けるのに使用される第2の固定位置に移動可能である、装置。 - 更に、前記アンカーをその第2の固定位置に固定し、かつ、前記移動可能な本体部分が前記初期位置に戻ることを防止するための楔部を有する、請求項8に記載の装置。
- 腱を骨に結合させるシステムであって、
アンカーを有し、このアンカーは、骨及び腱に取付けられ、腱とアンカーと骨との間の取付けは、元に戻せる固定であり、前記アンカーは、実質的に非円形の断面を有する、システム。 - 更に、前記アンカーを骨内に展開するための展開装置を有する、請求項10に記載のシステム。
- 前記アンカーは、骨内の内部空間に取付けられる、請求項10に記載のシステム。
- 骨内の前記内部空間は、前記アンカーが入る孔を有する、請求項12に記載のシステム。
- 前記アンカーは、壁を有し、この壁は、前記アンカーを骨内に導入するときの初期形態、及び、前記アンカーを骨内に押込んだ第2の形態から移動可能である、請求項10に記載のシステム。
- 前記アンカーは、更に、骨内での前記アンカーの入り込みを助けるタブを有する、請求項10に記載のシステム。
- 前記アンカーは、その外壁の少なくとも一部分が腱を骨の内面に押付けるように位置決めされる、請求項10に記載のシステム。
- 腱を骨に結合させるシステムであって、
骨及び腱を互いに固定するための固定手段を有し、骨及び腱は、腱とアンカーと骨との間の取付けが元に戻せる固定であるように取付けられ、
前記固定手段は、実質的に非円形の断面を有する、システム。 - 更に、前記固定手段を骨内に展開するための展開手段を有する、請求項17に記載のシステム。
- 前記固定手段は、壁を有し、この壁は、前記アンカーを骨内に導入するときの初期形態、及び、前記アンカーを骨内に入れる第2形態から移動可能である、請求項17に記載のシステム。
- 腱を骨に結合させる方法であって、
腱を実質的に非円筒形のアンカーで取外し可能に支持する工程と、
前記アンカーを骨に取付ける工程と、を有する方法。
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- 2005-11-18 WO PCT/US2005/041924 patent/WO2006055823A2/en active Application Filing
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Also Published As
Publication number | Publication date |
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AU2005306450B2 (en) | 2011-09-29 |
JP4589457B1 (ja) | 2010-12-01 |
US20060155287A1 (en) | 2006-07-13 |
US8435294B2 (en) | 2013-05-07 |
US20100152850A1 (en) | 2010-06-17 |
WO2006055823A2 (en) | 2006-05-26 |
AU2005306450A1 (en) | 2006-05-26 |
US7651528B2 (en) | 2010-01-26 |
EP1824395A4 (en) | 2012-07-18 |
EP1824395A2 (en) | 2007-08-29 |
JP4603047B2 (ja) | 2010-12-22 |
WO2006055823A3 (en) | 2006-09-08 |
JP2010279731A (ja) | 2010-12-16 |
EP1824395B1 (en) | 2019-07-03 |
AU2005306450B9 (en) | 2012-02-02 |
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